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Lumenis

Last updated May 23, 2026

What Lumenis makes

The company manufactures surgical laser systems, including solid-state and carbon dioxide laser platforms for general and ENT procedures, along with reusable and single-use beam guides and adaptors. Their portfolio also includes tissue morcellation systems and handpieces for powered tissue fragmentation, as well as micromanipulators for precise ENT surgery applications.

These devices are regulated under FDA classifications, with most falling under Class II and some under Class III. They are listed in the FDA’s 510(k), PMA, and UDI registries, reflecting their authorised status for commercial distribution in the US market.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Lumenis manufacture?

Lumenis specialises in surgical laser systems, including solid-state and carbon dioxide laser platforms designed for general and ENT (ear, nose, and throat) procedures. Their portfolio also includes reusable and single-use beam guides, laser adaptors, tissue morcellation systems, handpieces for tissue fragmentation, and micromanipulators for precise ENT surgery. These devices are engineered for applications like tissue ablation, coagulation, and fragmentation in various surgical settings.

Where is Lumenis based, and does that affect its regulatory oversight?

Lumenis is headquartered in the United States, which means its devices are subject to FDA regulatory oversight. The FDA classifies Lumenis’s products as either Class II or Class III, depending on their risk level and intended use. This classification determines the regulatory pathway for authorisation, such as 510(k) clearance for Class II devices or PMA approval for Class III devices, ensuring compliance with US market requirements.

Which regulatory registries list Lumenis’s devices?

Lumenis’s devices are listed in key FDA registries, including the 510(k) Premarket Notification Database, the Premarket Approval (PMA) Application Database, and the Unique Device Identifier (UDI) System. These registries track authorised devices for commercial distribution in the US, ensuring transparency and compliance with FDA requirements for surgical lasers and related systems.

How are Lumenis’s devices classified under FDA regulations?

Lumenis’s devices are classified under the FDA’s risk-based system, with most falling under Class II, which requires a 510(k) clearance to demonstrate substantial equivalence to a predicate device. Some higher-risk devices, such as certain laser systems or tissue morcellation tools, are classified as Class III, requiring a Premarket Approval (PMA) application to ensure safety and effectiveness before market authorisation. Classification depends on factors like procedural invasiveness and potential patient risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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Catalogue (577)

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Device	Model / Reference	Registries	Class	Status
Versapulse Model P20 Laser System	K100228	FDA 510(k)	Class II	Active
Novus Verdi Delivery Systems	K991258	FDA 510(k)	Class II	Active
Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System In Combination With The Coherent Argons	K973470	FDA 510(k)	Class II	Active
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System	K162837	FDA 510(k)	Class II	Active
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO	K180597	FDA 510(k)	Class II	Active
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	K202428	FDA 510(k)	Class II	Active
Novus Ttx Laser And Delivery Devices With Accessories	K032357	FDA 510(k)	Class II	Active
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories	K170121	FDA 510(k)	Class II	Active
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity	K170179	FDA 510(k)	Class II	Active
Lumenis Family Of Ipl And Combination Ipl/Nd:yag Systems	K030527	FDA 510(k)	Class II	Active
Coherent Xa-50, X30/Cw, Xa30/Sp Surgical Lasers	K895143	FDA 510(k)	Class II	Active
Modified Versapulse Select Ho:yag And Ho:yag/Nd:yag Lasers	K980685	FDA 510(k)	Class II	Active
Opusduo; Opusduo E; Opusduo Ec; Opus 20; Opus Spectrum	K040270	FDA 510(k)	Class II	Active
Lumenis Y&R Laser System	K211979	FDA 510(k)	Class II	Active
Lume 2 System, Model Ga0005000	K083733	FDA 510(k)	Class II	Active
Resurfx 1565nm Laser Module	K130028	FDA 510(k)	Class II	Active
Family Of Selecta Ophthalmic Laser Systems (selecta 1064, Selecta Slt, Selecta Duo), Delivery Device And Accessories	K051944	FDA 510(k)	Class II	Active
Coherent Tissue Morcellator Kit And Accessories	K980079	FDA 510(k)	Class II	Active
Lumenis Pulse 120h	K140388	FDA 510(k)	Class II	Active
Coherent Family Of Co2 Surgical Laser Scanner Handpieces	K946304	FDA 510(k)	Class II	Active
Fiberlase Endure Co2 Fiber	K130164	FDA 510(k)	Class II	Active
The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch	K151331	FDA 510(k)	Class II	Active
Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers And Delivery Device Accessories	K022060	FDA 510(k)	Class II	Active
Argon Microsurigal Protocols	K810740	FDA 510(k)	Class II	Active
Vision One Laser System	K111213	FDA 510(k)	Class II	Active
Coherent Pdl1 And Pdl2 Lambda Plus Photodynamic Lasers	P940011	FDA PMA	N/A	Active
Coherent Opal Photoactivator	P990049	FDA PMA	Class III	Active

Related Companies

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Lumenis has nine recall records listed in the FDA database, all initiated between April 8, 2005, and October 14, 2021, with all records marked as terminated. The reasons cited include potential unintended laser exposure, software errors leading to incorrect filter data, missing regulatory clearance, labeling discrepancies (e.g., incorrect fiber size markings), device design flaws (such as missing indicator markings or sapphire crystal debris), and contamination risks in associated ultrasound gels and lotions.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 14, 2021	Z-0194-2022	—	terminated	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Aug 15, 2014	Z-2733-2014	—	terminated	Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.
Aug 19, 2013	Z-2191-2013	—	terminated	Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Jul 27, 2010	Z-2652-2010	—	terminated	Firm did not have proper 510(K) clearance.
Dec 18, 2007	Z-0585-2008	—	terminated	Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.
Aug 29, 2006	Z-0028-2007	—	terminated	Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
Feb 9, 2006	Z-0556-06	—	terminated	During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
Feb 1, 2006	Z-0545-06	—	terminated	The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.
Apr 8, 2005	Z-0529-06	—	terminated	Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Lumenis, Ltd. YOKNEAM Northern · IL FEI 3004135191